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Currently open positions
Manager Biologics and GMP
Job description
Come join Spermosens, a leading developer of revolutionizing medical device products for male infertility, individualizing In Vitro Fertilization (IVF) diagnostics and treatment creating a new standard for faster and safer IVF treatments, as their Manager Biologics and GMP! With Spermosens first product, JUNO- Checked, it will – for the first time – be possible to determine a sperms ability to fertilize the egg cell. This in turn enables the IVF clinic to choose the appropriate fertilization treatment. Today, around 85 percent of IVF treatments fail. Being able to determine the sperm’s ability to fertilize the egg cell is expected to cause to a reduction in the number of IVF-treatments. As we are growing this is a new role and here you´ll get the chance to contribute with you expertise in for example recombinant protein production and purification and be part of causing a reduction in the number of IVF-treatments.
Qualifications
To thrive and perform well in this role, we believe that you bring the following experiences:
- PhD in biochemistry or industrial biotechnology.
- 3+ years industrial experience in recombinant protein production and purification.
- Knowledge of biophysical characterization techniques for quality control of proteins.
- 2+ years experience in GMP production of biologics and biopharmaceuticals.
- Experience in writing SOPs and technical documentation.
We will be extra happy if you also bring experience from production and purification of membrane proteins and/or nonenzymatic proteins from mammalian hosts and experience in biophysical characterization techniques for quality control of secondary and tertiary structures of proteins. Knowledge of human In Vitro Fertilization and Intracytoplasmic Sperm Injection and experience with statistical methods will also be seen as an advantage.
Your personality is defined by characteristics like entrepreneurial and self-driven. You care about the details while having the ability to take a step back and see the big picture. Furthermore, you are a natural leader with excellent communication skills who thrives in a diverse environment.
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.
Responsibilities
Current commercial methods to analyze the sperm quality only look into the physical aspects of the sperm. Spermosens is developing first of its kind automated sperm diagnostic device JUNO-Checked that relies of their ability to bind to egg cell-proteins. The approach will, for the first time, enable detection of fertilization capacity of sperms, and hence choice of the appropriate IVF treatment method. Spermosens aims at reducing the conventional iterations in IVF treatments to achieve pregnancy with JUNO-Checked.
As Manager Biologics and GMP you will be an important key player and responsible for our projects in developing our products. You´ll coordinate development activities and lead sourcing and outsourced production and purification of GMP and non-GMP recombinant proteins. Likewise, participate in research projects with partners and consultants on sperm selection and diagnostics. By bringing your knowledge and expertise, you will make a great and important impact of the lives of involuntarily childless couples. Depending on which experiences you bring, you will be part in shaping the role going forward. The position is based at the Headquarters in Lund and you will report to Head of Design and Development.
Some of the responsibilities in this role will also be:
- Establish specifications for quality control of recombinant proteins.
- Establish specifications for quality control of JUNO-Picked – Spermosens’ medical device for sperm selection.
- Conduct user interviews and establish user and market specifications for JUNO-Picked.
- Identify and establish GMP requirements on production, packaging and logistics of JUNO-Picked.
- Train on and work in accordance with Spermosens’ Quality Management System, populate SOPs and prepare technical documentation.
- Contribute to technical and marketing material for JUNO-Picked
Application
Please apply at the latest on 2022-04-19, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.
For more information please contact recruitment consultant Emelie Lanner, emelie.lanner@randstad.se or +46729733382.
About Spermosens AB
Developer of revolutionizing medical device products for male infertility, individualizing In Vitro Fertilization (IVF) diagnostics and treatment creating a new standard for faster and safer IVF treatments. Spermosens is listed on Spotlight Stock Market since 5th of May 2021.
Design quality engineer
Job description
Take the chance to be a part of Spermosens, a leading developer of revolutionizing medical device products for male infertility, individualizing In Vitro Fertilization (IVF) diagnostics and treatment creating a new standard for faster and safer IVF treatments! With Spermosens first product, JUNO- Checked, it will – for the first time – be possible to determine a sperms ability to fertilize the egg cell. This in turn enables the IVF clinic to choose the appropriate fertilization treatment. Today, around 85 percent of IVF treatments fail. Being able to determine the sperm’s ability to fertilize the egg cell is expected to cause to a reduction in the number of IVF-treatments. As we are growing this is a new role and here you´ll get the chance to contribute with you expertise in design control and manufacturing for medical devices and be part of making an impact of the lives of many childless couples.
Qualifications
To thrive and perform well in this role, we believe that you bring the following experiences and knowledge:
- Academic background in engineering/biomedical engineering or similar (bachelors or masters).
- Minimum 3 years professional experience in quality engineering/R&D or equivalent within medical devices.
- Expertise in design control and manufacturing for medical devices with at least 2 years experience supporting design and development projects for medical devices.
- Experience in quality management system standard ISO 13485, FDA QSR and national regulations MDD, MDR, IVDR.
- Fluent in English, both spoken and written.
If you also have experience in in vitro diagnostic medical devices and/or embedded software devices and experience in using eQMS it will be seen as a plus, like knowledge within Swedish.
We are searching for you who are comfortable in this role and who wants to grow and develop with our company. You need to have excellent communication skills since the role entails contacts with different stakeholders, both internally and externally. Furthermore, you love digging into details but at the same time, you have the ability to finish your tasks and meet deadlines.
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.
Responsibilities
The main purpose of this role is to support the Head of Product Design and Development, who you are reporting to, in design and development projects for Spermosens in-vitro diagnostic products. You bring your expertise within manufacturing, and coordinate technical activities during development of our products, in collaboration with development and manufacturing partners. You will also spend time on leading or participating in design control activities, including managing DHFs design history file, translating customer needs and identifying design input requirements, and planning V&V activities.
Other tasks included in the role will be:
- Preparation of technical documentation to support the RA Manager in submissions.
- Act as a Subject Matter Expert supporting CAPA and NC investigations.
- Participating in Risk Management activities.
Application
Please apply at the latest on 2022-05-20, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.
For more information please contact recruitment consultant Emelie Lanner, emelie.lanner@randstad.se or +46729733382.
About Spermosens AB
Developer of revolutionizing medical device products for male infertility, individualizing In Vitro Fertilization (IVF) diagnostics and treatment creating a new standard for faster and safer IVF treatments. Spermosens is listed on Spotlight Stock Market since 5th of May 2021.
